| 医疗器械与药品的说明书、标签管理规定对比研究 |
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| 引用本文： | 李竹,李非,迟戈,梁文,马艳彬,肇恒哲. 医疗器械与药品的说明书、标签管理规定对比研究[J]. 中国医疗器械信息, 2012, 0(10): 36-38,73 |
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| 作者姓名： | 李竹 李非 迟戈 梁文 马艳彬 肇恒哲 |
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| 作者单位： | 1. 辽宁省食品药品监督管理局技术审评中心 沈阳 110003
2. 沈阳市食品药品监督管理局 沈阳 110003 |
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| 摘 要： | 目的:通过医疗器械与药品在说明书、标签管理规定方面的对比研究,借鉴药品的管理经验,完善医疗器械的说明书、标签和包装标识的管理规定,保障医疗器械应用的安全性和有效性。方法及结果:基于国家法规及实际使用现状,结合药品与医疗器械关于说明书、标签、包装标识方面的规定对比,给出医疗器械说明书、标签和包装标识管理规定上的修订建议。结论:医疗器械应参照药品,结合实际应用情况,在说明书、标签和包装标识中规定应更加细化。
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| 关 键 词： | 医疗器械 药品 说明书 标签 对比研究 |
Comparative Study of Manual and Labeling Regulation in Medical Devices and Drugs |
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| LI Zhu,LI Fei,CHI Ge,LIANG Wen,MA Yan-bin,ZHAO Heng-zhe. Comparative Study of Manual and Labeling Regulation in Medical Devices and Drugs[J]. China Medical Devices Information, 2012, 0(10): 36-38,73 |
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| Authors: | LI Zhu LI Fei CHI Ge LIANG Wen MA Yan-bin ZHAO Heng-zhe |
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| Affiliation: | Liaoning Food and Drug Administration Technical Evaluation Center(Shenyang 110003) 2 Shenyang Food and Drug Administration(Shenyang 110003) |
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| Abstract: | Objective： By contrast drugs manual and labeling regulation in China,the medical devices manual and labeling regulation should be revised properly,to guarantee the safety and efficacy of medical device.Methods and Results： To analysis in manual and labeling regulation between drugs and medical devices,pointed out some advices for revising the regulation.Conclusions：A set of system for drug labeling has been established,the revise about medical devices regulation should draw experience,and make medical device labeling regulation more detailed. |
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| Keywords: | medical device drugs manual labeling comparative study |
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